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Functional Connectivity of the Interoceptive Network in RLS

Study acronym: IntoRLS
StatusRecruiting
PhaseNot applicable
Started2025-09-16
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 13 months later Oct 2026 → Dec 2027
See other at-risk trials from University Hospital, Bordeaux

Amendment history

2026-09-26
critical
Primary completion pushed: 2026-10 → 2027-12
Completion pushed: 2026-10 → 2027-12
2025-09-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-06→2026-10
Completion date2026-06→2026-10
Start dateestimated 2025-06→confirmed 2025-09-16
Study sitesdetails revised at 1 of 1 site
2025-05-23
minor
Original filing
Restless Legs Syndrome (RLS) is a sensorimotor disorder primarily characterized by an irresistible urge to move the legs while at rest. A key hypothesis suggests that RLS symptoms are linked to abnormal brain function in processing internally generated stimuli, particularly interoception. This distorted perception of the internal bodily state leads to maladaptive behaviors, which may manifest across a wide range of medical and psychiatric disorders. Here, the investigators hypothesize that dysfunction in the insular cortex (IC) may result in a failure of behavioral adaptation, primarily expressed as an urge to move the legs and hyperarousal, even when the body and mind need rest. This project aims to assess the relationship between interoceptive abilities and diurnal fluctuations in IC functional connectivity (FC) in patients with RLS compared to healthy controls. The investigators will also examine correlations between the FC of the interoceptive network, measured in the morning and evening on the same day, using multilayer network analysis, daily fluctuations in RLS symptom severity, and objective measurements of the sleep/wake cycle, gathered through a two-week ambulatory assessment using mobile technologies such as Ecological Momentary Assessment (EMA) and actigraphy, along with scores from self-reported questionnaires. The findings may provide strong evidence to support or refute the hypothesis of interoceptive dysfunction in RLS patients.
Trial Details
NCT Number NCT07001891
Lead Sponsor University Hospital, Bordeaux
Collaborators: Restless Legs Syndrome Foundation
Conditions Restless Legs Syndrome
Enrollment 30 participants
Start Date 2025-09-16
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-25